Support in Quality Control program under minimal supervision. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources. Responsible for providing technical guidance, provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise. Resolve technical issues and troubleshoot for assays as necessary. Manage existing and/or develop and implement new programs, processes and methodologies, Develop, revise and audit various complex controlled documents. Approve lab investigations, lead audit teams.
Doctorate degree in Sciences or master’s degree in Sciences & 3 years of directly related experience or Bachelor’s degree in Sciences & 5 years of directly related experience
Qualifications and Skills:
Ultimate Solutions Corp is an Equal Opportunity Employer.
- Experience in change control, CAPA and investigations
- Good interpersonal skills and problem solving
- Project Management skills
- Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
- Fully bilingual: oral and written
- Strong word processing, presentation, database and spreadsheet application skills
- Expertise in Technical Writing, must have written reports for investigations, method transfers/validations
- Oriented to solve problems and troubleshoot, technical proficiency
- Simple statistical assessments
- Knowledge in TrackWise, CDOCS, Maximo